Agreed PIPs for FDCs for the treatment of HIV-1 infection - - PowerPoint PPT Presentation

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Agreed PIPs for FDCs for the treatment of HIV-1 infection

Introduction for the HIV FDC Expert meeting

Presented by Andrea Ecker on 10 November 2015 Scientific Officer, Paediatric Medicines Office, Human Medicines Research and Development Support Division

• PDCO reviews FDCs for which the applicant pursues an EU marketing authorisation

in adults

• for a new product the legal obligation to complete the PIP is triggered when the

product is authorised in adults

• in some instances new active substances seem to be currently developed only in

FDCs, not individually

• each PIP is assessed individually on its own merits
• this presentation only includes public information

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General comments

HIV FDCs with an agreed PIP or waiver

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Active Substance ( nam e) PI P agreed in PI P com pleted ( com pletion date) FTC/ RPV/ TDF (Eviplera) * 2010 No (2019) EVG/ FTC/ TDF/ COBI (Stribild) * 2011 No (2020) LPV/ r (oral solution) (Kaletra) 2011 Yes ( 2 0 1 5 ) LPV/ r/ 3TC 2012 N/ A ( full w aiver) DTG/ ABC/ 3TC (Triumeq) * 2012 No (2019) DRV/ COBI (Rezolsta) 2013 No (2021) LPV/ 3TC/ r/ AZT * 2013 N/ A ( full w aiver) RAL/ 3TC (Dutrebris) 2014 Yes ( 2 0 1 4 ) EVG/ COBI/ FTC/ TAF* 2014 No (2017) ATV/ COBI (Evotaz) 2014 No (2019) FTC/ TAF 2015 No (2020) FTC/ TAF/ RPV * 2015 No (2021) * single-tablet regimen blue font = authorised in adults

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Active Substance ( nam e) PI P agreed in Current paediatric authorisation Age range of PI P FTC/ RPV/ TDF (Eviplera) * 2010 No > 6 years EVG/ FTC/ TDF/ COBI (Stribild) * 2011 No > 6 years LPV/ r (oral solution) (Kaletra) 2011 > 2 yrs 14 days - < 2 years DTG/ ABC/ 3TC (Triumeq) * 2012 > 1 2 yrs ( > 4 0 kg) > 2 years DRV/ COBI (Rezolsta) 2013 No > 3 years RAL/ 3TC (Dutrebris) 2014 > 6 yrs ( > 3 0 kg) > 6 years ( > 3 0 kg) EVG/ COBI/ FTC/ TAF* 2014 N/ A > 6 years ATV/ COBI (Evotaz) 2014 No > 3 months FTC/ TAF 2015 N/ A > 4 weeks FTC/ TAF/ RPV * 2015 N/ A > 4 weeks

HIV FDCs with an agreed PIP or waiver – age range

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Active Substance ( nam e) PI P agreed in Current paediatric authorisation Age range of PI P FTC/ RPV/ TDF (Eviplera) * 2010 No > 6 years EVG/ FTC/ TDF/ COBI (Stribild) * 2011 No > 6 years LPV/ r (oral solution) (Kaletra) 2011 > 2 yrs 14 days - < 2 years DTG/ ABC/ 3TC (Triumeq) * 2012 > 1 2 yrs ( > 4 0 kg) > 2 years DRV/ COBI (Rezolsta) 2013 No > 3 years RAL/ 3TC (Dutrebris) 2014 > 6 yrs ( > 3 0 kg) > 6 years ( > 3 0 kg) EVG/ COBI/ FTC/ TAF* 2014 N/ A > 6 years ATV/ COBI (Evotaz) 2014 No > 3 months FTC/ TAF 2015 N/ A > 4 weeks FTC/ TAF/ RPV * 2015 N/ A > 4 weeks

HIV FDCs with an agreed PIP or waiver – age range

Q1 / Q2 : Which age range for which product? Prioritisation criteria?

Development plans – Quality

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Active Substance ( nam e) Age range of PI P Agreed quality m easure ( intended age [ yrs] ) FTC/ RPV/ TDF (Eviplera) * > 6 years age appropriate film-coated tablet (6-12) EVG/ FTC/ TDF/ COBI (Stribild) * > 6 years age appropriate oral solid dosage form LPV/ r (oral solution) (Kaletra) 14 days - < 2 yrs n/ a DTG/ ABC/ 3TC (Triumeq) * > 2 years dispersible tablet DRV/ COBI (Rezolsta) > 3 years age-appropriate oral solid dosage form and age- appropriate oral liquid dosage form (3-12) RAL/ 3TC (Dutrebris) > 6 yrs (> 30 kg) n/ a EVG/ COBI/ FTC/ TAF* > 6 years age-appropriate film-coated tablet (6-12) ATV/ COBI (Evotaz) > 3 months film-coated tablet (adolescents > 40 kg) age-appropriate oral solid dosage form (3 mo-18) FTC/ TAF > 4 weeks film-coated tablet (6-12) age-appropriate oral formulation (< 6) FTC/ TAF/ RPV * > 4 weeks film-coated tablet (6-12) age-appropriate oral formulation (< 6)

Development plans – Quality

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Active Substance ( nam e) Age range of PI P Agreed quality m easure ( intended age [ yrs] ) FTC/ RPV/ TDF (Eviplera) * > 6 years age appropriate film-coated tablet (6-12) EVG/ FTC/ TDF/ COBI (Stribild) * > 6 years age appropriate oral solid dosage form LPV/ r (oral solution) (Kaletra) 14 days - < 2 yrs n/ a DTG/ ABC/ 3TC (Triumeq) * > 2 years dispersible tablet DRV/ COBI (Rezolsta) > 3 years age-appropriate oral solid dosage form and age- appropriate oral liquid dosage form (3-12) RAL/ 3TC (Dutrebris) > 6 yrs (> 30 kg) n/ a EVG/ COBI/ FTC/ TAF* > 6 years age-appropriate film-coated tablet (6-12) ATV/ COBI (Evotaz) > 3 months film-coated tablet (adolescents > 40 kg) age-appropriate oral solid dosage form (3 mo-18) FTC/ TAF > 4 weeks film-coated tablet (6-12) age-appropriate oral formulation (< 6) FTC/ TAF/ RPV * > 4 weeks film-coated tablet (6-12) age-appropriate oral formulation (< 6)

Q3 -5 : Feasibility (multiple FDCs in youngest children, diverging from individual active substance dosing, age cut-offs)? Q6 : use of the adult formulation in adolescents Q7 : What are desired AAFs?

Development plans – Clinical

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Active Substance ( nam e) Age range of PI P Clinical studies in FTC/ RPV/ TDF (Eviplera) * > 6 years 6-18 yrs EVG/ FTC/ TDF/ COBI (Stribild) * > 6 years 6-18 yrs LPV/ r (oral solution) (Kaletra) 14 days - < 2 yrs 14 weeks – 37 months DTG/ ABC/ 3TC (Triumeq) * > 2 years 2-12 yrs DRV/ COBI (Rezolsta) > 3 years 3-18 yrs RAL/ 3TC (Dutrebris) > 6 yrs (> 30 kg) healthy adults only EVG/ COBI/ FTC/ TAF* > 6 years 6-18 yrs ATV/ COBI (Evotaz) > 3 months healthy adults only FTC/ TAF > 4 weeks 4 weeks – 18 yrs FTC/ TAF/ RPV * > 4 weeks healthy adults only

Development plans – Clinical

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Active Substance ( nam e) Age range of PI P Clinical studies in FTC/ RPV/ TDF (Eviplera) * > 6 years 6-18 yrs EVG/ FTC/ TDF/ COBI (Stribild) * > 6 years 6-18 yrs LPV/ r (oral solution) (Kaletra) 14 days - < 2 yrs 14 weeks – 37 months DTG/ ABC/ 3TC (Triumeq) * > 2 years 2-12 yrs DRV/ COBI (Rezolsta) > 3 years 3-18 yrs RAL/ 3TC (Dutrebris) > 6 yrs (> 30 kg) healthy adults only EVG/ COBI/ FTC/ TAF* > 6 years 6-18 yrs ATV/ COBI (Evotaz) > 3 months healthy adults only FTC/ TAF > 4 weeks 4 weeks – 18 yrs FTC/ TAF/ RPV * > 4 weeks healthy adults only

Q7 : Acceptability/ palatability data in children? Q3 -5 : Feasibility (multiple FDCs in youngest children, diverging from individual active substance dosing, age cut-offs)? Q6 : Development in adolescents